Bio Pharma Dive
OCTOBER 16, 2020
Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't.
World of DTC Marketing
OCTOBER 12, 2020
WHAT? There is going to be more coverage for virtual doctors’ visits in new employee health plans along with expanded mental health benefits and access to on-site health clinics. Of course, this comes at an increased cost even though health insurers are making a lot of money. Employees for the most part are happy with their health insurance but that happiness is going to come at a higher cost.
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Camargo
OCTOBER 14, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Establishes Digital Health Center of Excellence. The FDA announced the launch of its Digital Health Center of Excellence (DHCoE) on September 22, marking an important step in its efforts to modernize digital health policies and regulatory approaches.
NY Times
OCTOBER 12, 2020
The months ahead will be difficult. But the medical cavalry is coming, and the rest of us know what we need to do.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Bio Pharma Dive
OCTOBER 16, 2020
Normally staid affairs, next Thursday's advisory committee meeting could be historic and set expectations for how the FDA will approach any future vaccine approval.
Pharma Times
OCTOBER 12, 2020
Two trials will involve over 6,000 participants at sites in and outside the US
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NY Times
OCTOBER 15, 2020
An antiviral widely used to treat hospitalized patients did not lower the mortality rate in a multinational trial.
Bio Pharma Dive
OCTOBER 14, 2020
The Swiss pharma is the third large drugmaker to partner with Harvard spinout Dyno Therapeutics, a small biotech aiming to improve gene therapy technology.
Pharma Times
OCTOBER 12, 2020
Oral S1P receptor modulator hit both primary endpoints in a phase III trial
pharmaphorum
OCTOBER 15, 2020
The boom in digital tech over COVID means that pharma can move faster than ever – but the industry’s traditional processes for asset approval are still holding timelines back. David Reily examines how pharma companies are responding to the increased burden of asset approval with new ways of working. The coronavirus pandemic has forced a traditionally risk-averse industry tied to legacy systems for regulation and compliance to fully embrace digital solutions in commercial and marketing functions.
Pharma Mirror
OCTOBER 14, 2020
Histoplasmosis is an inflammatory lung infection that usually occurs when a human has had contact with bird or bat droppings. Histoplasmosis is similar in symptoms to COVID-19, such as shortness of breath, fever, chest pain, and coughing. Some people who are at high-risk for histoplasmosis may also be concerned that they have contracted COVID-19. Though.
Bio Pharma Dive
OCTOBER 14, 2020
Safety signals in a mid-stage study led Vertex to stop work on one of its experimental drugs for the inherited disorder alpha-1 antitrypsin deficiency.
Pharma Times
OCTOBER 13, 2020
Biologic therapy hit primary and all key secondary endpoints in phase III
BioSpace
OCTOBER 13, 2020
Relief Therapeutics and NeuroRx released results on Tuesday from their open-label prospective study looking into RLF-100 (aviptadil) as a potential treatment for COVID-19 and respiratory failure.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
pharmaphorum
OCTOBER 16, 2020
Patients with heart failure often have a dismal prognosis as the condition usually worsens over time, but a new study aims to see if digital health technologies can improve their prospects. The trial – run by Boehringer Ingelheim and Yale University – will test a smart bathroom scale device that has cardiac monitoring built in, as well as an app to help patients improve their diet and lose weight and a digital assistant designed to motivate them to actively manage their health.
Bio Pharma Dive
OCTOBER 16, 2020
The results could weaken the case for widely using Veklury, also known as remdesivir, just as the company is asking for full approval from the FDA.
Pharma Times
OCTOBER 15, 2020
Drug is licensed for secondary progressive multiple sclerosis with active disease
BioSpace
OCTOBER 11, 2020
AstraZeneca signed a deal with Operation Warp Speed, the U.S. government program to advance COVID-19 vaccines and therapeutics, for a monoclonal antibody cocktail.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
World of DTC Marketing
OCTOBER 15, 2020
HEY NOW : Most companies struggled in the second quarter as the coronavirus pandemic froze the economy, but health insurers like UnitedHealth heavily benefited as people held off on going to the doctor or hospital, resulting in fewer medical claims that needed to be paid. In addition, pharma profit margins remain very high. UnitedHealth Group registered more than $6.6 billion in profits in the second quarter — by far the conglomerate’s highest quarterly profit ever, according to an ana
Bio Pharma Dive
OCTOBER 13, 2020
The company did not disclose details, nor could it confirm whether the participant had received its shot. But J&J is now the second vaccine developer, along with AstraZeneca, to suspend testing for a safety review.
Pharma Times
OCTOBER 15, 2020
Review draws on experiences of patients and expert consensus
Outsourcing Pharma
OCTOBER 12, 2020
Technology impacting generic drugs include artificial intelligence, telemedicine, fraud-preventing digital solutions and more, according to a report.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
pharmaphorum
OCTOBER 13, 2020
Ayming Group’s second annual International Innovation Barometer (IIB) has said that the international outlook for R&D is “remarkably promising” despite strong headwinds caused by COVID-19. The report reveals that R&D departments are being empowered by the creation of ‘innovation ecosystems’, new funding methods, and the deployment of technology.
Bio Pharma Dive
OCTOBER 16, 2020
An unusual letter from Pfizer chief Albert Bourla confirms that the drugmaker won't file for an approval of its experimental shot, assuming positive results, before the U.S. presidential election.
Pharma Times
OCTOBER 13, 2020
The committee accepted a number of drugs through the PACE process
BioSpace
OCTOBER 11, 2020
Moncef Slaoui, the head of Operation Warp Speed, suggested the first Emergency Use Authorization for a COVID-19 vaccine will likely be around Thanksgiving.
BioPharma Reporter
OCTOBER 12, 2020
A global trial, designed to test the theory that the BCG vaccine could help protect against COVID-19, will soon start recruitment in the UK.
Bio Pharma Dive
OCTOBER 13, 2020
We observe that the COVID-19 crisis shines a light on the benefits to patients and industry stakeholders of bringing clinical trials closer to patients' homes.
Pharma Times
OCTOBER 13, 2020
In a letter to Health Secretary Matt Hancock the RPS called for urgent action
BioSpace
OCTOBER 13, 2020
With multiple COVID-19 vaccines in development, the CDC is confident that any vaccines the FDA authorizes or approves will be safe because they are based on the FDA’s usual stringent protocols. The greater question, after a vaccine is approved, is how it will be distributed.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
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